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Item | Specifications | Results |
Appearance | White crystalline powder | White crystalline powder |
Assay | 99.0~101.0% | 99.9% |
Specific rotation | +22.4°~+24.8° | +23.7° |
pH | 5.6~6.1 | 5.9 |
Residue on ignition | ≤0.40% | 0.13% |
Chloride (CL) | ≤0.05% | 0.018% |
Loss on drying | ≤0.30% | 0.25% |
Sulfate(SO4) | ≤0.03% | 0.015% |
Iron,(Fe) | ≤30ppm | 7ppm |
Heavy metals ,(Pb) | ≤15ppm | 6ppm |
Organic volatile impurities | Meets the requirements | Conform |
Identification | Infrared absorption | Conform |
Market News:CHMP also recommended for approval Sanofi and Genzyme’s new Pompe disease drug, known in Europe as Nexviadyme (avalglucosidase alfa). Pompe disease is a rare, inherited disorder caused by the buildup of glycogen in the body’s cells. N,N-dimethyl-4-[(4-phenyl-1,3-thiazol-2-yl)iminomethyl]aniline manufacturer.EMA said the drug can help improve the respiratory function of Pompe disease patients, and the most common side effects include hypersensitivity (including anaphylaxis) and infusion-associated reactions. 4-(2-((6-((2-methyl-2-phenylpropyl)amino)hexyl)amino)ethyl)benzene-1,2-diol supplier.Moderna filed an application with the FDA for that same younger age group on June 10 but has yet to hear from the agency. States like Rhode Island have already signed off on allowing 12 to 17-year-olds to use the vaccine. 1,3-dimethyl-8-(1-methyl-2-oxo-propylsulfanyl)-3,7(9)-dihydro-purine-2,6-dione producer.
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